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BPL were in a position to issue information sheets which stated that the clinical trials of 8Y at six haemophilia centres showed that several patients had by then safely passed the point at which the first evidence of non-A non-B Hepatitis viral transmission would normally occur with non-heated Factor 8.
Published on:
16 September, 2024
BPL and PFC recalled unheated Factor 9 in October 1985.
Published on:
16 September, 2024
Dr Harris of Armour wrote to haemophilia centre directors recommending the return of all non-donor tested Factorate so that it could be exchanged for material manufactured from screened donations.
Published on:
16 September, 2024
An internal Cutter memo showed that all heat-treated product made commercially carried a significant, though reduced, risk of hepatitis. None had been eliminated.
Published on:
16 September, 2024
The Committee on Safety of Medicines considered the safety of heat-treated Factor 8.
Published on:
16 September, 2024
Dr Peter Fernandes accidently discovered an appropriate stabiliser and by December 1978 had moved on to show those which worked with the globulin could work with antihaemophilic factor.
Published on:
16 September, 2024
Behringwerke conducted initial experiments in heat treatment.
Published on:
16 September, 2024
Dr Milton Mozen, director of biochemical research and development at Cutter, said that "Concern about hepatitis transmission" was the reason for experiments with heat treatment in the early 1970s.
Published on:
16 September, 2024
David Castaldi from Hyland sent a memo to his distribution team about the decision to proceed with heat treating its product, on the basis not that it would eliminate hepatitis, but reduce the risk of it.
Published on:
16 September, 2024
Dr Shanbrom stated that he tried to persuade the four major manufacturers of factor concentrates to use a detergent process for viral inaction in the mid to late 1970s.
Published on:
16 September, 2024
Bruce L Evatt from the Center for Infectious Diseases wrote to Fred Feldman, Armour Pharmaceuticals regarding heat inactivation of LAV in clotting concentrates and two preliminary experiments that had been undertaken with regards to this.
Published on:
16 September, 2024
UK haemophilia reference centre directors sent a circular letter to all haemophilia centres with recommendations on choice on therapeutic products for the treatment of non-inhibitor patients with Haemophilia A, Haemophilia B or von Willebrand's Disease.
Published on:
16 September, 2024
Chiron Corporation identified, cloned and expressed proteins from Hepatitis non-A non-B virus, which may allow screening for previously undetectable disease.
Published on:
16 September, 2024
In the draft witness statement of Dr Snape, he stated that between May and October 1984 activities leading to the establishment of the 8Y process "began in earnest".
Published on:
16 September, 2024
All issues of Factor 8 were subjected to HT3 heat treatment. The product which was coded 8Y was made at both Oxford and Elstree.
Published on:
16 September, 2024
From May 1985, all Factor 8 issues by BPL/PFL had been heat treated under at least HT2 conditions.
Published on:
16 September, 2024
In a letter from Dr Rizza to Dr Alison Smithies, the DHSS stated that BPL would start releasing 8Y prepared from tested donors from the middle of August, and by the end of September, if not sooner, all NHS Factor 8 would be from tested donors.
Published on:
16 September, 2024
Peter Jones wrote to Medical Assessor, The Committee on Safety of Medicines urging that any material that had not been collected in low risk areas, been individually donor tested and heat treated in an approved manner, should be withheld, at the very least from seronegative people.
Published on:
16 September, 2024
In March 1984, BPL products made by combining a "small pool" approach and heat treatment were used for the first time.
Published on:
16 September, 2024
Preliminary results on the heat treatment of PFC Factor 8 concentrate were published.
Published on:
16 September, 2024
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